User login
Glucagon-like peptide 1 (GLP-1) receptor agonists are the latest blockbuster drugs — thanks to their potent ability to help patients lose weight. But
Semaglutide for weight loss (Wegovy) has launched in eight countries, namely, Denmark, Germany, Iceland, Norway, the United Arab Emirates, the United Kingdom, the United States, and Switzerland, and was released in Japan in February. Semaglutide for type 2 diabetes (Ozempic) is approved in 82 countries and often is prescribed off-label to treat obesity.
The dual glucose-dependent insulinotropic polypeptide/GLP-1 agonist tirzepatide — sold as Mounjaro for type 2 diabetes — started rolling out in 2022. It’s approved for chronic weight management in the European Union and the United Kingdom, sold in the United States as the weight loss drug Zepbound, and is currently under review in China.
As shortages continue, some governments are asking clinicians not to prescribe the drugs for obesity and instead reserve them for people with type 2 diabetes. But governments are limited in how to enforce this request, and some providers disagree with the guidance. Here’s a look at various countries’ approaches to handling these blockbuster drugs.
Sweden
Ylva Trolle Lagerros, MD, said it’s common for the Swedish Medicines Agency to post guidance for drugs on their website, and occasionally, the agency will send letters to physicians if a drug is recalled or found to have new side effects. In December, Dr. Lagerros, along with physicians throughout Sweden, received a letter at her home address requesting that they not prescribe GLP-1 receptor agonists to people for weight loss alone, over concerns the drugs wouldn’t be available for patients with type 2 diabetes.
Given the shortages, Dr. Lagerros, an obesity medicine specialist and associate professor at the Karolinska Institutet in Stockholm, Sweden, expected the guidance but said it was reinforced with the letters mailed to physicians’ homes.
“It’s not forbidden to go off-label. It is a right you have as a physician, but we are clearly told not to,” said Dr. Lagerros, who is also a senior physician at the Center for Obesity in Stockholm, Sweden’s largest obesity clinic.
Providers are being forced to prioritize some patients above others, she added.
“Yes, GLP-1 [agonists] are good for people with type 2 diabetes, but given this global shortage, I think the people who are most severely sick should be prioritized,” she said. “With this principle, we are walking away from that, saying only people with type 2 diabetes should get it.”
Dr. Lagerros said she does not prescribe Ozempic, the only injectable GLP-1 currently available in Sweden, off-label because she works closely with the government on national obesity guidelines and feels unable to, but she understands why some of her colleagues at other clinics do.
In Sweden, some companies are importing and selling Wegovy, which is typically not available, at different price points, said Dr. Lagerros. She said she knows of at least three telehealth apps operating in Sweden through which patients are prescribed semaglutide for weight loss without being seen by a doctor.
“That adds to the ethical problem that if you prescribe it as a diabetes medication, the patient doesn’t have to pay, but if you prescribe it as an obesity medication, the patient has to pay a lot of money,” Dr. Lagerros said.
United Kingdom
Last summer, health officials in the United Kingdom took a similar approach to Sweden’s, urging providers to stop prescribing appetite-suppressing medications for weight loss due to shortages for patients with diabetes. The notice also asked providers to hold off on writing new prescriptions for GLP-1 agonists, as well as the drug Trulicity, for patients with type 2 diabetes.
In the United Kingdom, Wegovy, Mounjaro, and Saxenda, an oral semaglutide, have been approved for weight loss and are covered by the National Health System. People must have a body mass index (BMI) of 30 or more with one weight-related condition, or a BMI of at least 35, to qualify for Wegovy. Because Ozempic, only approved for treating type 2 diabetes, is used off-label but is not specifically indicated for weight loss, physicians typically use the same parameters when prescribing it off-label as they do Wegovy.
Naresh Dr. Kanumilli, MD, a general practitioner and diabetes specialist in the Northenden Group Practice in Manchester, England, said he believes GLP-1 agonists should not be used off-label for weight loss.
“The global shortage was probably exacerbated because a lot of the drugs were going toward obesity when they should be going to diabetes,” he said.
Dr. Kanumilli, who is also a National Health Service England Clinical Network lead for diabetes, said he hopes more doctors in the United Kingdom offer their patients other drugs for weight loss before reaching for Wegovy.
He said doctors in the United Kingdom are allowing patients to jump from a metformin-only regimen to GLP-1 plus metformin, without trying an intermediate group of drugs called sodium-glucose transport protein 2 inhibitors. “We want to reinforce that these drugs should be tried prior to GLP-1 agonists [for obesity treatment],” he said.
United States
Despite widespread shortages, the US government has not asked clinicians to reserve GLP-1 agonists for patients with type 2 diabetes, but patients are experiencing additional restrictions related to cost and insurance coverage.
In the United States, where these types of medications already cost more than they do in other countries, private insurers rarely cover the drugs for obesity. Medicare is forbidden to cover any type of weight loss drug, although proposed legislation could change that.
According to August 2023 data from KFF, formerly The Kaiser Family Foundation, a month’s supply of a 1.7-mg or 2.4-mg dose of Wegovy costs an average of $1349 in the United States, which is considerably higher than other countries. In Germany, that same supply runs about $328. In the Netherlands, it’s $296. A 1-month supply of Rybelsus or Ozempic costs about four times as much in the United States as it does in the Netherlands. Eli Lilly’s list price for 1 month of Mounjaro in the United States is $1069.08 compared to about $319 in Japan, according to the report.
On the rare occasion a private insurer in the United States does cover a GLP-1 agonist prescribed for weight loss — only about 27% of insurance companies did in 2023 — people may need to prove other interventions, including lifestyle changes, did not produce results.
Beverly Tchang, MD, an assistant professor of clinical medicine at Weill Comprehensive Weight Control Center in New York, said she takes a patient-by-patient approach when considering prescribing these medications.
The BMI thresholds for Wegovy are 27 if a person has at least one weight-related comorbidity, and 30 if they do not, in the United States. Dr. Tchang said these rules are strict, but some exceptions are made for ethnicities such as those of South or East Asian descent where a BMI of 25 can be used as they have a lower threshold for overweight or obesity.
If Dr. Tchang feels a patient would benefit from significant weight loss, she is comfortable prescribing the drugs for weight loss to a patient who doesn’t have type 2 diabetes.
“Most people I see would benefit from that 10%-15% or more weight loss threshold, so I often do reach for the tirzepatide and semaglutide,” she said.
For patients who need to lose closer to 5% of their body weight to manage or prevent comorbidities, Dr. Tchang said she would likely try another medication that does not produce as extreme results.
Canada
The Canadian government has not directed clinicians to reserve GLP-1 agonists for certain patients. Instead, access is limited by cost, said Ehud Ur, MD, a professor of medicine at the University of British Columbia and consulting endocrinologist at St. Paul’s Hospital in Vancouver, British Columbia, Canada.
About 67% of Canadians have private insurance, according to The Commonwealth Fund. Most private insurers cover GLP-1 agonists for weight loss, but Canada’s public healthcare system only covers the drugs for type 2 diabetes, not for weight loss alone.
He agreed that people with type 2 diabetes should not be favored over those with obesity for prescriptions of GLP-1 agonists. Rather, he said, physicians should focus on what is the best treatment is for each patient. For some people with obesity, these medications can elicit the same weight loss as surgery, which no other medication currently can.
Dr. Ur said some clinicians in Canada prescribe GLP-1 agonists to people who do not need to lose a significant amount of weight, but the drugs are also being taken by people who do.
“The drive for the drugs is largely due to their efficacy,” he said. “You have physicians that have more confidence in this drug than they have for any other antiobesity agent, so you have a big drive for prescriptions.”
What Are the Alternatives?
In the face of shortages, physicians including Dr. Lagerros, Dr. Tchang, and Dr. Ur are resorting to other drugs when necessary to get patients the care they need.
“We have been in the business of treating obesity for decades,” Dr. Tchang said. “Before the GLP-1s were invented.”
Dr. Lagerros does not believe all her patients need GLP-1 agonists but does want them more widely available for those who overeat because they are unable to control their appetite, who she said are prime candidates for the drugs.
“I’m telling my patients, ‘yes, we don’t have semaglutide right now, but we just have to hang in there and work with what we have right now,’” she said.
A version of this article appeared on Medscape.com.
Glucagon-like peptide 1 (GLP-1) receptor agonists are the latest blockbuster drugs — thanks to their potent ability to help patients lose weight. But
Semaglutide for weight loss (Wegovy) has launched in eight countries, namely, Denmark, Germany, Iceland, Norway, the United Arab Emirates, the United Kingdom, the United States, and Switzerland, and was released in Japan in February. Semaglutide for type 2 diabetes (Ozempic) is approved in 82 countries and often is prescribed off-label to treat obesity.
The dual glucose-dependent insulinotropic polypeptide/GLP-1 agonist tirzepatide — sold as Mounjaro for type 2 diabetes — started rolling out in 2022. It’s approved for chronic weight management in the European Union and the United Kingdom, sold in the United States as the weight loss drug Zepbound, and is currently under review in China.
As shortages continue, some governments are asking clinicians not to prescribe the drugs for obesity and instead reserve them for people with type 2 diabetes. But governments are limited in how to enforce this request, and some providers disagree with the guidance. Here’s a look at various countries’ approaches to handling these blockbuster drugs.
Sweden
Ylva Trolle Lagerros, MD, said it’s common for the Swedish Medicines Agency to post guidance for drugs on their website, and occasionally, the agency will send letters to physicians if a drug is recalled or found to have new side effects. In December, Dr. Lagerros, along with physicians throughout Sweden, received a letter at her home address requesting that they not prescribe GLP-1 receptor agonists to people for weight loss alone, over concerns the drugs wouldn’t be available for patients with type 2 diabetes.
Given the shortages, Dr. Lagerros, an obesity medicine specialist and associate professor at the Karolinska Institutet in Stockholm, Sweden, expected the guidance but said it was reinforced with the letters mailed to physicians’ homes.
“It’s not forbidden to go off-label. It is a right you have as a physician, but we are clearly told not to,” said Dr. Lagerros, who is also a senior physician at the Center for Obesity in Stockholm, Sweden’s largest obesity clinic.
Providers are being forced to prioritize some patients above others, she added.
“Yes, GLP-1 [agonists] are good for people with type 2 diabetes, but given this global shortage, I think the people who are most severely sick should be prioritized,” she said. “With this principle, we are walking away from that, saying only people with type 2 diabetes should get it.”
Dr. Lagerros said she does not prescribe Ozempic, the only injectable GLP-1 currently available in Sweden, off-label because she works closely with the government on national obesity guidelines and feels unable to, but she understands why some of her colleagues at other clinics do.
In Sweden, some companies are importing and selling Wegovy, which is typically not available, at different price points, said Dr. Lagerros. She said she knows of at least three telehealth apps operating in Sweden through which patients are prescribed semaglutide for weight loss without being seen by a doctor.
“That adds to the ethical problem that if you prescribe it as a diabetes medication, the patient doesn’t have to pay, but if you prescribe it as an obesity medication, the patient has to pay a lot of money,” Dr. Lagerros said.
United Kingdom
Last summer, health officials in the United Kingdom took a similar approach to Sweden’s, urging providers to stop prescribing appetite-suppressing medications for weight loss due to shortages for patients with diabetes. The notice also asked providers to hold off on writing new prescriptions for GLP-1 agonists, as well as the drug Trulicity, for patients with type 2 diabetes.
In the United Kingdom, Wegovy, Mounjaro, and Saxenda, an oral semaglutide, have been approved for weight loss and are covered by the National Health System. People must have a body mass index (BMI) of 30 or more with one weight-related condition, or a BMI of at least 35, to qualify for Wegovy. Because Ozempic, only approved for treating type 2 diabetes, is used off-label but is not specifically indicated for weight loss, physicians typically use the same parameters when prescribing it off-label as they do Wegovy.
Naresh Dr. Kanumilli, MD, a general practitioner and diabetes specialist in the Northenden Group Practice in Manchester, England, said he believes GLP-1 agonists should not be used off-label for weight loss.
“The global shortage was probably exacerbated because a lot of the drugs were going toward obesity when they should be going to diabetes,” he said.
Dr. Kanumilli, who is also a National Health Service England Clinical Network lead for diabetes, said he hopes more doctors in the United Kingdom offer their patients other drugs for weight loss before reaching for Wegovy.
He said doctors in the United Kingdom are allowing patients to jump from a metformin-only regimen to GLP-1 plus metformin, without trying an intermediate group of drugs called sodium-glucose transport protein 2 inhibitors. “We want to reinforce that these drugs should be tried prior to GLP-1 agonists [for obesity treatment],” he said.
United States
Despite widespread shortages, the US government has not asked clinicians to reserve GLP-1 agonists for patients with type 2 diabetes, but patients are experiencing additional restrictions related to cost and insurance coverage.
In the United States, where these types of medications already cost more than they do in other countries, private insurers rarely cover the drugs for obesity. Medicare is forbidden to cover any type of weight loss drug, although proposed legislation could change that.
According to August 2023 data from KFF, formerly The Kaiser Family Foundation, a month’s supply of a 1.7-mg or 2.4-mg dose of Wegovy costs an average of $1349 in the United States, which is considerably higher than other countries. In Germany, that same supply runs about $328. In the Netherlands, it’s $296. A 1-month supply of Rybelsus or Ozempic costs about four times as much in the United States as it does in the Netherlands. Eli Lilly’s list price for 1 month of Mounjaro in the United States is $1069.08 compared to about $319 in Japan, according to the report.
On the rare occasion a private insurer in the United States does cover a GLP-1 agonist prescribed for weight loss — only about 27% of insurance companies did in 2023 — people may need to prove other interventions, including lifestyle changes, did not produce results.
Beverly Tchang, MD, an assistant professor of clinical medicine at Weill Comprehensive Weight Control Center in New York, said she takes a patient-by-patient approach when considering prescribing these medications.
The BMI thresholds for Wegovy are 27 if a person has at least one weight-related comorbidity, and 30 if they do not, in the United States. Dr. Tchang said these rules are strict, but some exceptions are made for ethnicities such as those of South or East Asian descent where a BMI of 25 can be used as they have a lower threshold for overweight or obesity.
If Dr. Tchang feels a patient would benefit from significant weight loss, she is comfortable prescribing the drugs for weight loss to a patient who doesn’t have type 2 diabetes.
“Most people I see would benefit from that 10%-15% or more weight loss threshold, so I often do reach for the tirzepatide and semaglutide,” she said.
For patients who need to lose closer to 5% of their body weight to manage or prevent comorbidities, Dr. Tchang said she would likely try another medication that does not produce as extreme results.
Canada
The Canadian government has not directed clinicians to reserve GLP-1 agonists for certain patients. Instead, access is limited by cost, said Ehud Ur, MD, a professor of medicine at the University of British Columbia and consulting endocrinologist at St. Paul’s Hospital in Vancouver, British Columbia, Canada.
About 67% of Canadians have private insurance, according to The Commonwealth Fund. Most private insurers cover GLP-1 agonists for weight loss, but Canada’s public healthcare system only covers the drugs for type 2 diabetes, not for weight loss alone.
He agreed that people with type 2 diabetes should not be favored over those with obesity for prescriptions of GLP-1 agonists. Rather, he said, physicians should focus on what is the best treatment is for each patient. For some people with obesity, these medications can elicit the same weight loss as surgery, which no other medication currently can.
Dr. Ur said some clinicians in Canada prescribe GLP-1 agonists to people who do not need to lose a significant amount of weight, but the drugs are also being taken by people who do.
“The drive for the drugs is largely due to their efficacy,” he said. “You have physicians that have more confidence in this drug than they have for any other antiobesity agent, so you have a big drive for prescriptions.”
What Are the Alternatives?
In the face of shortages, physicians including Dr. Lagerros, Dr. Tchang, and Dr. Ur are resorting to other drugs when necessary to get patients the care they need.
“We have been in the business of treating obesity for decades,” Dr. Tchang said. “Before the GLP-1s were invented.”
Dr. Lagerros does not believe all her patients need GLP-1 agonists but does want them more widely available for those who overeat because they are unable to control their appetite, who she said are prime candidates for the drugs.
“I’m telling my patients, ‘yes, we don’t have semaglutide right now, but we just have to hang in there and work with what we have right now,’” she said.
A version of this article appeared on Medscape.com.
Glucagon-like peptide 1 (GLP-1) receptor agonists are the latest blockbuster drugs — thanks to their potent ability to help patients lose weight. But
Semaglutide for weight loss (Wegovy) has launched in eight countries, namely, Denmark, Germany, Iceland, Norway, the United Arab Emirates, the United Kingdom, the United States, and Switzerland, and was released in Japan in February. Semaglutide for type 2 diabetes (Ozempic) is approved in 82 countries and often is prescribed off-label to treat obesity.
The dual glucose-dependent insulinotropic polypeptide/GLP-1 agonist tirzepatide — sold as Mounjaro for type 2 diabetes — started rolling out in 2022. It’s approved for chronic weight management in the European Union and the United Kingdom, sold in the United States as the weight loss drug Zepbound, and is currently under review in China.
As shortages continue, some governments are asking clinicians not to prescribe the drugs for obesity and instead reserve them for people with type 2 diabetes. But governments are limited in how to enforce this request, and some providers disagree with the guidance. Here’s a look at various countries’ approaches to handling these blockbuster drugs.
Sweden
Ylva Trolle Lagerros, MD, said it’s common for the Swedish Medicines Agency to post guidance for drugs on their website, and occasionally, the agency will send letters to physicians if a drug is recalled or found to have new side effects. In December, Dr. Lagerros, along with physicians throughout Sweden, received a letter at her home address requesting that they not prescribe GLP-1 receptor agonists to people for weight loss alone, over concerns the drugs wouldn’t be available for patients with type 2 diabetes.
Given the shortages, Dr. Lagerros, an obesity medicine specialist and associate professor at the Karolinska Institutet in Stockholm, Sweden, expected the guidance but said it was reinforced with the letters mailed to physicians’ homes.
“It’s not forbidden to go off-label. It is a right you have as a physician, but we are clearly told not to,” said Dr. Lagerros, who is also a senior physician at the Center for Obesity in Stockholm, Sweden’s largest obesity clinic.
Providers are being forced to prioritize some patients above others, she added.
“Yes, GLP-1 [agonists] are good for people with type 2 diabetes, but given this global shortage, I think the people who are most severely sick should be prioritized,” she said. “With this principle, we are walking away from that, saying only people with type 2 diabetes should get it.”
Dr. Lagerros said she does not prescribe Ozempic, the only injectable GLP-1 currently available in Sweden, off-label because she works closely with the government on national obesity guidelines and feels unable to, but she understands why some of her colleagues at other clinics do.
In Sweden, some companies are importing and selling Wegovy, which is typically not available, at different price points, said Dr. Lagerros. She said she knows of at least three telehealth apps operating in Sweden through which patients are prescribed semaglutide for weight loss without being seen by a doctor.
“That adds to the ethical problem that if you prescribe it as a diabetes medication, the patient doesn’t have to pay, but if you prescribe it as an obesity medication, the patient has to pay a lot of money,” Dr. Lagerros said.
United Kingdom
Last summer, health officials in the United Kingdom took a similar approach to Sweden’s, urging providers to stop prescribing appetite-suppressing medications for weight loss due to shortages for patients with diabetes. The notice also asked providers to hold off on writing new prescriptions for GLP-1 agonists, as well as the drug Trulicity, for patients with type 2 diabetes.
In the United Kingdom, Wegovy, Mounjaro, and Saxenda, an oral semaglutide, have been approved for weight loss and are covered by the National Health System. People must have a body mass index (BMI) of 30 or more with one weight-related condition, or a BMI of at least 35, to qualify for Wegovy. Because Ozempic, only approved for treating type 2 diabetes, is used off-label but is not specifically indicated for weight loss, physicians typically use the same parameters when prescribing it off-label as they do Wegovy.
Naresh Dr. Kanumilli, MD, a general practitioner and diabetes specialist in the Northenden Group Practice in Manchester, England, said he believes GLP-1 agonists should not be used off-label for weight loss.
“The global shortage was probably exacerbated because a lot of the drugs were going toward obesity when they should be going to diabetes,” he said.
Dr. Kanumilli, who is also a National Health Service England Clinical Network lead for diabetes, said he hopes more doctors in the United Kingdom offer their patients other drugs for weight loss before reaching for Wegovy.
He said doctors in the United Kingdom are allowing patients to jump from a metformin-only regimen to GLP-1 plus metformin, without trying an intermediate group of drugs called sodium-glucose transport protein 2 inhibitors. “We want to reinforce that these drugs should be tried prior to GLP-1 agonists [for obesity treatment],” he said.
United States
Despite widespread shortages, the US government has not asked clinicians to reserve GLP-1 agonists for patients with type 2 diabetes, but patients are experiencing additional restrictions related to cost and insurance coverage.
In the United States, where these types of medications already cost more than they do in other countries, private insurers rarely cover the drugs for obesity. Medicare is forbidden to cover any type of weight loss drug, although proposed legislation could change that.
According to August 2023 data from KFF, formerly The Kaiser Family Foundation, a month’s supply of a 1.7-mg or 2.4-mg dose of Wegovy costs an average of $1349 in the United States, which is considerably higher than other countries. In Germany, that same supply runs about $328. In the Netherlands, it’s $296. A 1-month supply of Rybelsus or Ozempic costs about four times as much in the United States as it does in the Netherlands. Eli Lilly’s list price for 1 month of Mounjaro in the United States is $1069.08 compared to about $319 in Japan, according to the report.
On the rare occasion a private insurer in the United States does cover a GLP-1 agonist prescribed for weight loss — only about 27% of insurance companies did in 2023 — people may need to prove other interventions, including lifestyle changes, did not produce results.
Beverly Tchang, MD, an assistant professor of clinical medicine at Weill Comprehensive Weight Control Center in New York, said she takes a patient-by-patient approach when considering prescribing these medications.
The BMI thresholds for Wegovy are 27 if a person has at least one weight-related comorbidity, and 30 if they do not, in the United States. Dr. Tchang said these rules are strict, but some exceptions are made for ethnicities such as those of South or East Asian descent where a BMI of 25 can be used as they have a lower threshold for overweight or obesity.
If Dr. Tchang feels a patient would benefit from significant weight loss, she is comfortable prescribing the drugs for weight loss to a patient who doesn’t have type 2 diabetes.
“Most people I see would benefit from that 10%-15% or more weight loss threshold, so I often do reach for the tirzepatide and semaglutide,” she said.
For patients who need to lose closer to 5% of their body weight to manage or prevent comorbidities, Dr. Tchang said she would likely try another medication that does not produce as extreme results.
Canada
The Canadian government has not directed clinicians to reserve GLP-1 agonists for certain patients. Instead, access is limited by cost, said Ehud Ur, MD, a professor of medicine at the University of British Columbia and consulting endocrinologist at St. Paul’s Hospital in Vancouver, British Columbia, Canada.
About 67% of Canadians have private insurance, according to The Commonwealth Fund. Most private insurers cover GLP-1 agonists for weight loss, but Canada’s public healthcare system only covers the drugs for type 2 diabetes, not for weight loss alone.
He agreed that people with type 2 diabetes should not be favored over those with obesity for prescriptions of GLP-1 agonists. Rather, he said, physicians should focus on what is the best treatment is for each patient. For some people with obesity, these medications can elicit the same weight loss as surgery, which no other medication currently can.
Dr. Ur said some clinicians in Canada prescribe GLP-1 agonists to people who do not need to lose a significant amount of weight, but the drugs are also being taken by people who do.
“The drive for the drugs is largely due to their efficacy,” he said. “You have physicians that have more confidence in this drug than they have for any other antiobesity agent, so you have a big drive for prescriptions.”
What Are the Alternatives?
In the face of shortages, physicians including Dr. Lagerros, Dr. Tchang, and Dr. Ur are resorting to other drugs when necessary to get patients the care they need.
“We have been in the business of treating obesity for decades,” Dr. Tchang said. “Before the GLP-1s were invented.”
Dr. Lagerros does not believe all her patients need GLP-1 agonists but does want them more widely available for those who overeat because they are unable to control their appetite, who she said are prime candidates for the drugs.
“I’m telling my patients, ‘yes, we don’t have semaglutide right now, but we just have to hang in there and work with what we have right now,’” she said.
A version of this article appeared on Medscape.com.